May 26, 2019
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       Florida Senate - 2010                                    SB 1722
       
       
       
       By Senator Fasano
       
       
       
       
       11-00747B-10                                          20101722__
    1                        A bill to be entitled                      
    2         An act relating to the prescription drug monitoring
    3         program; amending s. 893.055, F.S.; requiring that the
    4         comprehensive electronic database system containing
    5         information concerning prescriptions of controlled
    6         substances comply with the minimum requirements for
    7         authentication and certification of the National All
    8         Schedules Prescription Electronic Reporting Act;
    9         requiring the Department of Health to provide reports
   10         from the prescription drug monitoring program to the
   11         Department of Law Enforcement; requiring the
   12         Department of Health, in conjunction with the
   13         Department of Law Enforcement and other associations,
   14         to adopt rules; requiring the Department of Health to
   15         establish a method to allow corrections to the program
   16         database; revising the information to be submitted to
   17         the program database by a pharmacy or prescriber;
   18         revising the acts of dispensing or administering
   19         controlled substances which are exempt from reporting;
   20         requiring a pharmacy, prescriber, practitioner, or
   21         dispenser to register with the Department of Health in
   22         order to obtain certain information from the
   23         prescription drug monitoring program; requiring the
   24         program manager and certain other individuals who have
   25         access to the prescription drug monitoring program
   26         database to submit fingerprints to the Department of
   27         Health; requiring the Department of Health to follow
   28         the proper procedures established by the Department of
   29         Law Enforcement to request state and national criminal
   30         history record checks; prohibiting the Agency for
   31         Health Care Administration from having direct access
   32         to information in the prescription drug monitoring
   33         program database for purposes of Medicaid fraud cases
   34         or investigations; requiring a patient, legal
   35         guardian, or designated health care surrogate to
   36         provide the patient’s phone number and a copy of a
   37         government-issued photo identification in order to
   38         verify information in the prescription drug monitoring
   39         program database; providing an effective date.
   40  
   41  Be It Enacted by the Legislature of the State of Florida:
   42  
   43         Section 1. Subsections (2), (3), (5), and (7) of section
   44  893.055, Florida Statutes, are amended to read:
   45         893.055 Prescription drug monitoring program.—
   46         (2)(a) By December 1, 2010, the department shall design and
   47  establish a comprehensive electronic database system that has
   48  controlled substance prescriptions provided to it and that
   49  provides prescription information to a patient’s health care
   50  practitioner and pharmacist who inform the department that they
   51  wish the patient advisory report provided to them. Otherwise,
   52  the patient advisory report will not be sent to the
   53  practitioner, pharmacy, or pharmacist. The system shall be
   54  designed to provide information regarding dispensed
   55  prescriptions of controlled substances and shall not infringe
   56  upon the legitimate prescribing or dispensing of a controlled
   57  substance by a prescriber or dispenser acting in good faith and
   58  in the course of professional practice. The system shall be
   59  consistent with standards of the American Society for Automation
   60  in Pharmacy (ASAP). The electronic system shall also comply with
   61  the Health Insurance Portability and Accountability Act (HIPAA)
   62  as it pertains to protected health information (PHI), electronic
   63  protected health information (EPHI), the National All Schedules
   64  Prescription Electronic Reporting (NASPER) Act’s minimum
   65  requirements for authentication of a practitioner that requests
   66  information in the prescription drug monitoring program database
   67  and certification of the purpose for which information is
   68  requested, and all other relevant state and federal privacy and
   69  security laws and regulations. The department shall establish
   70  policies and procedures as appropriate regarding the reporting,
   71  accessing the database, evaluation, management, development,
   72  implementation, operation, storage, and security of information
   73  within the system. The reporting of prescribed controlled
   74  substances shall include a dispensing transaction with a
   75  dispenser pursuant to chapter 465 or through a dispensing
   76  transaction to an individual or address in this state with a
   77  pharmacy that is not located in this state but that is otherwise
   78  subject to the jurisdiction of this state as to that dispensing
   79  transaction. The reporting of patient advisory reports refers
   80  only to reports to patients, pharmacies, and practitioners.
   81  Separate reports that contain patient prescription history
   82  information and that are not patient advisory reports are
   83  provided to persons and entities as authorized in paragraphs
   84  (7)(b) and (c) and s. 893.0551.
   85         (b)1. The department’s prescription drug monitoring program
   86  shall:
   87         a. Provide reports directly to the Department of Law
   88  Enforcement without review by the department or a regulatory
   89  board so that the Department of Law Enforcement may investigate
   90  whether any violation of law has occurred regarding controlled
   91  substances in Schedule II, Schedule III, or Schedule IV; and
   92         b. Report, if applicable, the information to the
   93  appropriate state attorney or other law enforcement agency in
   94  accordance with state law.
   95  
   96  The parameters for such reports shall be adopted by rule of the
   97  department and developed in conjunction with the Department of
   98  Law Enforcement, the Florida Medical Association, the Florida
   99  Osteopathic Medicine Association, and the Florida Pain Society.
  100         2. The department, when the direct support organization
  101  receives at least $20,000 in nonstate moneys or the state
  102  receives at least $20,000 in federal grants for the prescription
  103  drug monitoring program, and in consultation with the Office of
  104  Drug Control, shall adopt rules as necessary concerning the
  105  reporting, accessing the database, evaluation, management,
  106  development, implementation, operation, security, and storage of
  107  information within the system, including rules for when patient
  108  advisory reports are provided to pharmacies and prescribers. The
  109  patient advisory report shall be provided in accordance with s.
  110  893.13(7)(a)8. The department shall work with the professional
  111  health care licensure boards, such as the Board of Medicine, the
  112  Board of Osteopathic Medicine, and the Board of Pharmacy; other
  113  appropriate organizations, such as the Florida Pharmacy
  114  Association, the Office of Drug Control, the Florida Medical
  115  Association, the Florida Retail Federation, and the Florida
  116  Osteopathic Medical Association, including those relating to
  117  pain management; and the Attorney General, the Department of Law
  118  Enforcement, and the Agency for Health Care Administration to
  119  develop rules appropriate for the prescription drug monitoring
  120  program.
  121         (c) All dispensers and prescribers subject to these
  122  reporting requirements shall be notified by the department of
  123  the implementation date for such reporting requirements.
  124         (d) The department shall establish a method to allow
  125  corrections to the database when notified by a health care
  126  practitioner or pharmacist.
  127         (3) The pharmacy dispensing the controlled substance and
  128  each prescriber who directly dispenses a controlled substance
  129  shall submit to the electronic system, by a procedure and in a
  130  format established by the department and consistent with an
  131  ASAP-approved format, the following information for inclusion in
  132  the database:
  133         (a) The name of the prescribing practitioner, the
  134  practitioner’s federal Drug Enforcement Administration
  135  registration number, the practitioner’s National Provider
  136  Identification (NPI) or other appropriate identifier, and the
  137  date of the prescription.
  138         (b) The date the prescription was filled and the method of
  139  payment, such as cash by an individual, insurance coverage
  140  through a third party, or Medicaid payment. This paragraph does
  141  not authorize the department to include individual credit card
  142  numbers or other account numbers in the database.
  143         (c) The full name, address, and date of birth of the person
  144  for whom the prescription was written.
  145         (d) The name, national drug code, quantity, and strength of
  146  the controlled substance dispensed.
  147         (e) The full name, federal Drug Enforcement Administration
  148  registration number, and address of the pharmacy or other
  149  location from which the controlled substance was dispensed. If
  150  the controlled substance was dispensed by a practitioner other
  151  than a pharmacist, the practitioner’s full name, federal Drug
  152  Enforcement Administration registration number, and address.
  153         (f) The name of the pharmacy or practitioner, other than a
  154  pharmacist, dispensing the controlled substance and the
  155  practitioner’s National Provider Identification (NPI).
  156         (g) Other appropriate identifying information as determined
  157  by department rule.
  158         (h) The number of refills ordered and whether the drug was
  159  dispensed as a refill of a prescription or was a first-time
  160  request.
  161         (5) When the following acts of dispensing or administering
  162  occur, the following are exempt from reporting under this
  163  section for that specific act of dispensing or administration:
  164         (a) A health care practitioner when administering a
  165  controlled substance directly to a patient if the amount of the
  166  controlled substance is adequate to treat the patient during
  167  that particular treatment session.
  168         (b) A pharmacist or health care practitioner when
  169  administering a controlled substance to a patient or resident
  170  receiving care as a patient at a hospital, nursing home,
  171  ambulatory surgical center, hospice, or intermediate care
  172  facility for the developmentally disabled which is licensed in
  173  this state.
  174         (c)A practitioner when administering or dispensing a
  175  controlled substance in the health care system of the Department
  176  of Corrections.
  177         (c)(d) A practitioner when administering a controlled
  178  substance in the emergency room of a licensed hospital.
  179         (d)(e) A health care practitioner when administering or
  180  dispensing a controlled substance directly to a patient person
  181  under the age of 16 if the amount of the controlled substance is
  182  adequate to treat the patient during that particular treatment
  183  session.
  184         (e)(f) A pharmacist or a dispensing practitioner when
  185  dispensing a one-time, 48-hour 72-hour emergency resupply of a
  186  controlled substance to a patient.
  187         (7)(a) A practitioner or pharmacist who dispenses a
  188  controlled substance must submit the information required by
  189  this section in an electronic or other method in an ASAP format
  190  approved by rule of the department unless otherwise provided in
  191  this section. The cost to the dispenser in submitting the
  192  information required by this section may not be material or
  193  extraordinary. Costs not considered to be material or
  194  extraordinary include, but are not limited to, regular postage,
  195  electronic media, regular electronic mail, and facsimile
  196  charges.
  197         (b)1.In order for a pharmacy, prescriber, practitioner, or
  198  dispenser to shall have access to information in the
  199  prescription drug monitoring program’s database which relates to
  200  a patient of that pharmacy, prescriber, practitioner, or
  201  dispenser, the pharmacy, prescriber, practitioner, or dispenser
  202  shall register with the department by submitting a registration
  203  document provided by the department in a manner established by
  204  the department as needed for the purpose of reviewing the
  205  patient’s controlled substance prescription history. The
  206  registration document must be notarized before it is submitted
  207  to the department. Before a pharmacy, prescriber, practitioner,
  208  or dispenser is granted access to information in the
  209  prescription drug monitoring program’s database, the submitted
  210  document must be approved by the department. Upon approval, the
  211  department shall grant the registrant access to the appropriate
  212  information in the prescription drug monitoring program’s
  213  database.
  214         2. Other access to the program’s database shall be limited
  215  to the program program’s manager and to the designated program
  216  and support staff, who may act only at the direction of the
  217  program manager or, in the absence of the program manager, as
  218  authorized. Access by the program manager or such designated
  219  staff is for prescription drug program management only or for
  220  management of the program’s database and its system in support
  221  of the requirements of this section and in furtherance of the
  222  prescription drug monitoring program. Confidential and exempt
  223  information in the database shall be released only as provided
  224  in paragraph (c) and s. 893.0551. The program manager,
  225  designated program and support staff who act at the direction of
  226  or in the absence of the program manager, and any individual who
  227  has similar access regarding the management of the prescription
  228  drug monitoring program database must submit fingerprints to the
  229  department for background screening. The department shall follow
  230  the procedure established by the Department of Law Enforcement
  231  to request a statewide criminal history record check and to
  232  request that the Department of Law Enforcement forward the
  233  fingerprints to the Federal Bureau of Investigation for a
  234  national criminal history record check.
  235         (c) The following entities shall not be allowed direct
  236  access to information in the prescription drug monitoring
  237  program database but may request from the program manager and,
  238  when authorized by the program manager, the program manager’s
  239  program and support staff, information that is confidential and
  240  exempt under s. 893.0551. Prior to release, the request shall be
  241  verified as authentic and authorized with the requesting
  242  organization by the program manager, the program manager’s
  243  program and support staff, or as determined in rules by the
  244  department as being authentic and as having been authorized by
  245  the requesting entity:
  246         1. The department or its relevant health care regulatory
  247  boards responsible for the licensure, regulation, or discipline
  248  of practitioners, pharmacists, or other persons who are
  249  authorized to prescribe, administer, or dispense controlled
  250  substances and who are involved in a specific controlled
  251  substance investigation involving a designated person for one or
  252  more prescribed controlled substances.
  253         2. The Attorney General or the Agency for Health Care
  254  Administration for Medicaid fraud cases or Medicaid
  255  investigations involving prescribed controlled substances.
  256         3. A law enforcement agency during active investigations
  257  regarding potential criminal activity, fraud, or theft regarding
  258  prescribed controlled substances.
  259         4. A patient or the legal guardian or designated health
  260  care surrogate of an incapacitated patient as described in s.
  261  893.0551 who, for the purpose of verifying the accuracy of the
  262  database information, submits a written and notarized request
  263  that includes the patient’s full name, address, and date of
  264  birth, and includes the same information if the legal guardian
  265  or health care surrogate submits the request. The patient’s
  266  phone number and a copy of a government-issued photo
  267  identification must be provided in person to the program manager
  268  along with the notarized request. The request shall be validated
  269  by the department to verify the identity of the patient and the
  270  legal guardian or health care surrogate, if the patient’s legal
  271  guardian or health care surrogate is the requestor. Such
  272  verification is also required for any request to change a
  273  patient’s prescription history or other information related to
  274  his or her information in the electronic database.
  275  
  276  Information in the database for the electronic prescription drug
  277  monitoring system is not discoverable or admissible in any civil
  278  or administrative action, except in an investigation and
  279  disciplinary proceeding by the department or the appropriate
  280  regulatory board.
  281         (d) The following entities shall not be allowed direct
  282  access to information in the prescription drug monitoring
  283  program database but may request from the program manager and,
  284  when authorized by the program manager, the program manager’s
  285  program and support staff, information that contains no
  286  identifying information of any patient, physician, health care
  287  practitioner, prescriber, or dispenser and that is not
  288  confidential and exempt:
  289         1. Department staff for the purpose of calculating
  290  performance measures pursuant to subsection (8).
  291         2. The Program Implementation and Oversight Task Force for
  292  its reporting to the Governor, the President of the Senate, and
  293  the Speaker of the House of Representatives regarding the
  294  prescription drug monitoring program. This subparagraph expires
  295  July 1, 2012.
  296         (e) All transmissions of data required by this section must
  297  comply with relevant state and federal privacy and security laws
  298  and regulations. However, any authorized agency or person under
  299  s. 893.0551 receiving such information as allowed by s. 893.0551
  300  may maintain the information received for up to 24 months before
  301  purging it from his or her records or maintain it for longer
  302  than 24 months if the information is pertinent to ongoing health
  303  care or an active law enforcement investigation or prosecution.
  304         Section 2. This act shall take effect July 1, 2010.

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